Dry Eye Clinical Trial
Official title:
Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model
The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.
Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range from
20 million people in the United States being affected with mild to moderate dry eye, to as
many as one out of every five Americans.
EyeGate completed a single-center, randomized, double-masked, placebo-controlled Phase 2
efficacy study in 105 subjects with mild to moderate dry eye disease, utilizing the
Controlled Adverse Environment (CAE), a clinical model which allows for standardized
measurement of dry eye signs and symptoms in the investigation of therapeutic agents. In
this Phase 2 study, the improvements documented in dry eye signs and symptoms relative to
the placebo group indicated that the ocular iontophoresis treatments with EGP-437
(dexamethasone phosphate formulated for ocular iontophoresis) had both a rapid onset of
action and a long-term effectiveness.
The Phase 3 study is intended to confirm and extend the results from the Phase 2 study,
utilizing the CAE model. The study is designed to assess the safety and efficacy of EGP-437
at two different dose levels: Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and
Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA compared to Ocular Iontophoresis with
placebo (sodium citrate buffer solution) for the treatment of the signs and symptoms of dry
eye.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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